The Recall Desk
Agency classClass IIOur severity:CriticalFDA (Devices)·Z-1257-2025·Announced 2025-03-12

Insulin pump recall: Medtronic Paradigm models malfunction during airplane flight

Medtronic MiniMed's Paradigm insulin pumps can malfunction during airplane flight due to air pressure changes, potentially causing dangerously high or low blood sugar levels that could be fatal.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source explicitly states that the insulin delivery malfunction can result in death during both take-off and landing. Per the severity rubric, any source mentioning death warrants a Critical severity score regardless of agency classification.

Plain-English summary

Medtronic MiniMed, Inc. is recalling Paradigm series insulin pumps and related models (Minimed 530G, 6XX series, and 7XX series) affecting approximately 41,404 units distributed worldwide, including throughout the United States.

The pumps can malfunction during airplane flight due to changes in air pressure. During take-off, the pump may deliver an unexpected additional dose of insulin, potentially causing severe hypoglycemia (dangerously low blood sugar), altered mental status, seizures, coma, or death. During landing, the pump may deliver an insufficient dose, potentially causing severe hyperglycemia (dangerously high blood sugar), dehydration, diabetic ketoacidosis, or death.

This recall affects all users of the affected pump models.

The recalled product

Product
Paradigm insulin pump, REF: MMT-754
Manufacturer
Medtronic MiniMed, Inc.
Category
Medical Device — Insulin Pump
Hazard
Affected units
41,404

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • All Lot Numbers
  • All UDI numbers

Distribution

Distributed nationwide across the United States.

The notice also names 53 states specifically:

Part of a larger recall action

This product is one of 12 recalled by Medtronic MiniMed, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →

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